J44 J45
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - patients must be capable to fill out an questionnaire on their quality of life - patients with a COPD or Asthma bronchiale and FEV1 between 50 % and 80 % - stable pulmonary medication without any changes in the last seven days - written informed consent
Exclusion criteria
Exclusion criteria: - acute exacerbation of the pulmonary disease - allergy against bee or wasp stings - restrictive lung disorders - malignant disease which is not yet cured - diseases with a life expectancy less than 6 months - heart insufficiency with an ejection fraction of less than 40 % - imprisoned individuals or mental immature adults - pregnant or breastfeeding patients - women of child bearing potential not using contraception - drug and alcohol abuse - patients not capable of giving consent - severe cognitive deficits or dementia - participation in other clinical studies - persons who may be dependet on the sponsor or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, measured by FEV1 (%). The efficacy is considered as verified when the FEV1 has improved by 6 % after the inhalation of the beehive air. Measuring time points: before study start and after beehive air therapy. The efficacy will be measured by a questionnaire (SF-36) and evaluation by the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, measured by: 1) occurences of allergic reactions or anaphylactic shock during or immediately after inhalation of the beehive air 2) dyspnoea during the inhalation of the beehive air or deterioration of FEV1 immediately after the beehive air inhalation. | — |
Countries
Germany
Contacts
Praxis